Viburcol^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Biologische Heilmittel Heel, GmbH (Germany)

ATC Code

V30 (Not assigned)

Dosage Form

Viburcol®

Homeopathic rectal suppositories for children: 12 pcs.

Dosage Form, Packaging, and Composition

Homeopathic rectal suppositories for children from white to yellowish-white in color, torpedo-shaped, with a faint characteristic odor (without a rancid odor); a longitudinal section may show the presence of an air core or a funnel-shaped depression.

Excipients: hard fat* – 1089.0 mg.
Suppository mass 1.1 g.

* a mixture of triglycerides, diglycerides, and monoglycerides of vegetable origin.

6 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Homeopathic preparation used for respiratory diseases

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic remedy, the action of which is due to the components that make up its composition.

Indications

• Use as part of complex therapy for respiratory diseases in children, where it functions as an antipyretic and anti-inflammatory agent.

• Employ for the relief of clinical manifestations associated with the eruption of milk teeth in children.

ICD codes

Dosage Regimen

Administer rectally. For acute respiratory viral infections and painful symptoms of milk teeth eruption in children under 6 months, use 1 suppository 2 times/day.

For children from 6 months with a body temperature above 37.5°C (99.5°F), use 1 suppository 4 times/day. For a body temperature above 38°C (100.4°F), use 1 suppository up to 6 times/day.

After normalization of body temperature, continue with 1 suppository 1-2 times/day for another 3-4 days to consolidate the effect.

Adverse Reactions

Allergic reactions are possible following administration. Monitor for skin rash, itching, or urticaria.

Very rarely (less than 1 case in 10,000 applications), moderate diarrhea may develop. If any of these or other side effects occur, discontinue use and consult a doctor immediately.

Contraindications

• Do not use in patients with a known hypersensitivity to the active components of the drug, including Chamomilla recutita, Atropa bella-donna, Solanum dulcamara, Plantago major, Pulsatilla pratensis, or Calcium carbonicum Hahnemanni.

• Do not use in patients with a known hypersensitivity to any of the excipients, specifically the hard fat (a mixture of triglycerides, diglycerides, and monoglycerides of vegetable origin) used in the suppository base.

Use in Pregnancy and Lactation

Used only in children.

Special Precautions

When taking homeopathic medicines, existing symptoms may temporarily worsen. In this case, you should stop using the drug and consult your doctor.

Drug Interactions

The use of this homeopathic remedy does not exclude treatment with other medicines. No specific pharmacokinetic or pharmacodynamic interactions with other medicinal products are currently known.

Concomitant use with other antipyretics or anti-inflammatory drugs is possible, but always inform your physician about all medications the child is taking.

Overdose

No cases of overdose have been reported to date. Given the homeopathic composition and the low concentrations of active ingredients, serious toxic effects are not expected.

In the event of suspected overdose and the appearance of any unusual symptoms, discontinue use immediately and seek medical advice. Treatment should be symptomatic and supportive if necessary.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.